Temozolomide glenmark

Package leaflet: Information for the user

Temozolomide Glenmark, 5 mg, hard capsules
Temozolomide Glenmark, 20 mg, hard capsules
Temozolomide Glenmark, 100 mg, hard capsules
Temozolomide Glenmark, 140 mg, hard capsules
Temozolomide Glenmark, 180 mg, hard capsules
Temozolomide Glenmark, 250 mg, hard capsules
Temozolomide
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

1. What Temozolomide Glenmark is and what it is used for
2. What you need to know before taking Temozolomide Glenmark
3. How to take Temozolomide Glenmark
4. Possible side effects
5. How to store Temozolomide Glenmark
6. Contents of the pack and other information

1. What Temozolomide Glenmark is and what it is used for

Temozolomide Glenmark contains a substance called temozolomide. This medicine is an
anticancer agent.
Temozolomide Glenmark is indicated for the treatment of certain types of brain tumours:

• in adults with newly diagnosed glioblastoma multiforme. Temozolomide Glenmark is first administered concomitantly with radiotherapy (the concomitant treatment phase), followed by administration as a single agent (the monotherapy phase).
• in children aged 3 years and older and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma. Temozolomide Glenmark is used to treat these tumours when there is evidence of tumour recurrence or disease progression following standard therapy.

2. Important information before using Temozolomide Glenmark

When not to use Temozolomide Glenmark

• if the patient is allergic to temozolomide or any of the other ingredients of this medicine (listed in section 6).
• if the patient has hypersensitivity to dacarbazine (an anticancer medicine, sometimes called DTIC). Symptoms of an allergic reaction include itching, breathlessness or wheezing, swelling of the face, lips, tongue or throat.
• if there is a significant decrease in the number of certain blood cells (due to bone marrow suppression), such as white blood cells or platelets. These blood cells play an

important role in fighting infections and the blood clotting process. The treating doctor will perform a blood test
before starting treatment to ensure that the number of these blood cells is adequate.
Warnings and precautions
Before starting treatment with Temozolomide Glenmark, discuss this with your doctor,
pharmacist, or nurse:

• if the patient under close monitoring develops severe lung infection caused by the microorganism Pneumocystis jirovecii (also known as Pneumocystis jirovecii pneumonia – PCP). Patients with newly diagnosed glioblastoma multiforme will receive Temozolomide Glenmark in a 42-day treatment schedule in combination with radiotherapy. In such cases, the treating doctor will also prescribe medications to help prevent the development of this type of lung infection (PCP).
• if the patient has ever had or may currently have hepatitis B virus infection. This is necessary because Temozolomide Glenmark may cause reactivation of hepatitis B virus infection, which in some cases may lead to death. Before starting treatment, patients will be carefully examined by the doctor to detect signs of this infection.
• if before starting or during treatment there is a reduced number of red blood cells (anaemia), white blood cells and platelets, or if there are problems with blood clotting. In such cases, the treating doctor may reduce the dose, interrupt, stop or change the treatment. Additional treatment may also be necessary. In some cases, discontinuation of treatment with Temozolomide Glenmark may be required. During treatment, the doctor will recommend frequent blood tests to monitor the undesirable effects of Temozolomide Glenmark on blood cells.
• if there is a small risk of other blood changes, including development of leukaemia.
• if nausea and/or vomiting occur, which are very common side effects associated with the use of Temozolomide Glenmark (see section 4), the treating doctor may prescribe antiemetic medicines (medicines to prevent vomiting). If frequent vomiting occurs before or during treatment, ask the doctor for advice on the most suitable time to take Temozolomide Glenmark, when vomiting does not occur. If vomiting occurs after taking the medicine, do not take a second dose on the same day.
• if fever or signs of infection occur, contact the treating doctor immediately.
• if the patient is over 70 years of age, they may be more susceptible to infections, have an increased tendency to bruising or bleeding.
• if the patient has liver or kidney disease, dose adjustment of Temozolomide Glenmark may be necessary.

Children and adolescents
Do not give this medicine to children under 3 years of age, as adequate studies have not been conducted. The amount of data available in patients over 3 years of age who have received Temozolomide Glenmark is limited.
Temozolomide Glenmark and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Pregnancy, breastfeeding and fertility
If the patient is pregnant, suspects she may be pregnant, or is planning to have a child, she should
consult her doctor or pharmacist before using this medicine. Do not use Temozolomide Glenmark during pregnancy unless the treating doctor specifically recommends such treatment.
During treatment with Temozolomide Glenmark and for at least 6 months after treatment ends, women who could become pregnant should use effective contraception.
Breastfeeding must be discontinued during treatment with Temozolomide Glenmark.
Male fertility
Temozolomide Glenmark may cause permanent infertility. Men receiving Temozolomide Glenmark should use effective contraception and must not father a child during treatment and for at least 3 months after treatment ends. It is recommended that patients consult their doctor to consider sperm preservation before starting treatment.
Driving and using machines
During treatment with Temozolomide Glenmark, fatigue or drowsiness may occur. Do not drive or operate machinery until the patient knows how this medicine affects them (see section 4).
Temozolomide Glenmark contains lactose
Temozolomide Glenmark contains lactose (a type of sugar). If the doctor has previously diagnosed the patient with intolerance to certain sugars, the patient should contact the treating doctor before taking this medicine.
Temozolomide Glenmark contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means the medicine is considered "sodium-free".

3. How to use Temozolomide Glenmark

This medicine should always be used exactly as instructed by the doctor or pharmacist. If in doubt,
consult the doctor or pharmacist.
Dosage and duration of treatment
The treating doctor will recommend the appropriate dose of Temozolomide Glenmark for the individual patient.
The dose is determined based on the patient's body size (height and weight) and depending on
whether the tumour has recurred and whether the patient has previously received chemotherapy. To prevent
nausea and vomiting or to reduce them, the doctor may prescribe other medicines (antiemetic medicines)
to be taken before and (or) after taking Temozolomide Glenmark.
Patients with newly diagnosed glioblastoma multiforme:
In newly diagnosed patients, treatment consists of two phases:

• first, Temozolomide Glenmark is given in combination with radiotherapy (concomitant treatment phase)
• then, Temozolomide Glenmark is given alone (monotherapy phase).

During concomitant treatment, the treating doctor will start Temozolomide
Glenmark at a dose of 75 mg/m² body surface area (the commonly used dose). The recommended dose is
taken daily for 42 days (up to 49 days) in combination with radiotherapy. Depending on blood test
results and the patient's tolerance to the medicine during concomitant treatment, the doctor may
delay or interrupt treatment with Temozolomide Glenmark. After completion of radiotherapy, a 4-
week treatment break will follow to allow the patient to recover. Then, the monotherapy phase will begin.
During monotherapy, Temozolomide Glenmark is given at a different dose and in a different manner. The treating
doctor will determine the appropriate dose of the medicine for the individual patient. The patient may receive up to 6 treatment periods
(cycles). Each cycle lasts 28 days. The patient will take only Temozolomide
Glenmark at the new dose once daily for the first 5 days of each cycle ("medication days").
The initial dose is 150 mg/m² body surface area. Then, for the next 23 days, the patient will not
take Temozolomide Glenmark. This constitutes a 28-day treatment cycle. On
day 28, the next treatment cycle will begin. The patient will again take Temozolomide Glenmark once daily for 5 days, followed by 23 days without the medicine. Depending on

blood test results and the patient's tolerance to the medicine in each treatment cycle, the doctor may
adjust the dose, delay, or interrupt treatment with Temozolomide Glenmark.
Patients with recurrent tumour growth or disease progression (malignant glioma, such as glioblastoma
multiforme or anaplastic astrocytoma) receiving only Temozolomide Glenmark:
The treatment cycle with Temozolomide Glenmark lasts 28 days. The patient takes only
Temozolomide Glenmark once daily for the first 5 days. The daily dose depends on whether
the patient has previously received chemotherapy.
If the patient has not previously received chemotherapy, the initial dose of Temozolomide
Glenmark will be 200 mg/m² body surface area once daily for the first 5 days. If the patient
has previously received chemotherapy, the initial dose of Temozolomide Glenmark will
be 150 mg/m² body surface area once daily for the first 5 days. For the next 23 days, the patient
will not take Temozolomide Glenmark. This constitutes a 28-day treatment cycle.
On day 28, the next treatment cycle will begin. The patient will again take Temozolomide
Glenmark once daily for 5 days, followed by 23 days without the medicine.
Before starting each new cycle, the doctor will perform a blood test to determine whether the dose of
Temozolomide Glenmark needs to be adjusted. Depending on blood test results, the treating doctor
may adjust the dose in the next cycle.
How to take Temozolomide Glenmark
The recommended dose of Temozolomide Glenmark should be taken once daily, preferably at the same
time each day.
The capsules should be taken on an empty stomach; for example, at least one hour before the planned
breakfast. The capsule(s) should be swallowed whole with a glass of water. Do not open, crush, or chew the capsules. If a capsule is damaged, avoid contact of its
contents with skin, eyes, or nose. If accidental contact occurs with eyes or nose,
the affected area should be thoroughly rinsed with water.
Depending on the prescribed dose, the patient may take more than one capsule at the same time
or may take capsules of different strengths (with different active substance content expressed in
milligrams). The cap colour of each capsule varies depending on the strength (see table below).

The patient must be certain that they have fully understood and remembered the following information:

• how many capsules they should take each day of treatment. The patient should ask their doctor or pharmacist to write down this information (including the color of the capsule cap).
• which days are treatment days.

Before starting each new cycle, the patient must receive again from their doctor the dosing instructions, as these may differ from the previous cycle.
Temozolomide Glenmark must always be taken exactly as prescribed by the doctor. It is very important to consult the doctor or pharmacist if there are any doubts. Errors in the way the medicine is taken may have serious consequences for the patient's health.

Taking more than the recommended dose of Temozolomide Glenmark
If the patient accidentally takes more capsules of Temozolomide Glenmark than prescribed, they should immediately contact their doctor, pharmacist, or nurse.

Missing a dose of Temozolomide Glenmark
A missed dose should be taken as soon as possible on the same day. If a full day has passed since the missed dose, the patient should contact their doctor. The patient must not take a double dose to make up for a missed dose, unless specifically instructed by the doctor.

If there are any further doubts about the use of this medicine, the patient should consult their doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
You should contact your doctor immediately if any of the following symptoms occur:

• severe allergic reaction (hypersensitivity) (urticaria, wheezing or other breathing problems)
• uncontrolled bleeding
• seizures (convulsions)
• fever
• chills
• severe, persistent headaches

Treatment with Temozolomide Glenmark may cause a decrease in certain types of blood cells. This may lead to increased bruising or bleeding, anaemia (reduced number of red blood cells), fever and reduced resistance to infections.
A decrease in blood cell counts is usually temporary. In some cases, it may persist and lead to a very severe form of anaemia (aplastic anaemia).
Your doctor will regularly order blood tests and, based on the results, decide whether any appropriate treatment is required. In some patients, it may be necessary to reduce the dose or discontinue treatment.
Other reported adverse reactions are listed below:
Very common adverse reactions (may affect more than 1 in 10 people):

• loss of appetite, speech difficulties, headache
• constipation, nausea, vomiting, diarrhoea
• rash, hair loss
• fatigue.

Common adverse reactions (may affect up to 1 in 10 people):

• infections, oral infections
• decreased number of blood cells (neutropenia, lymphopenia, thrombocytopenia)
• allergic reaction
• increased blood glucose levels
• memory impairment, depression, anxiety, confusion, insomnia or difficulty maintaining sleep
• coordination and balance disorders
• difficulty concentrating, change in mental state or alertness, forgetfulness
• dizziness, sensory disturbances, tingling sensation, tremors, taste disturbances
• partial loss of vision, abnormal vision, double vision, eye pain
• deafness, ringing in the ears, ear pain
• blood clots in the lungs or legs, high blood pressure
• pneumonia, shortness of breath, bronchitis, cough, sinusitis
• abdominal or stomach pain, stomach upset/heartburn, difficulty swallowing
• dry skin, itching
• muscle damage, muscle weakness, muscle pain
• joint pain, back pain
• frequent urination, difficulty controlling urine
• fever, flu-like symptoms, pain, malaise, cold or flu
• fluid retention, swelling of legs
• increased liver enzyme activity
• weight loss, weight gain
• radiation-induced tissue damage

Uncommon adverse reactions (may affect up to 1 in 100 people):

• brain infections (herpes simplex encephalitis), including fatal cases
• wound infections
• new or reactivation of cytomegalovirus infection
• reactivation of hepatitis B virus infection
• secondary malignancies, including leukaemia
• decreased number of blood cells (pancytopenia, anaemia, leukopenia)
• red spots under the skin
• diabetes insipidus (symptoms include increased urination and thirst), low blood potassium levels
• mood changes, hallucinations
• partial paralysis, altered sense of smell
• hearing disorders, middle ear infection
• palpitations (awareness of heartbeat), hot flushes
• stomach swelling, difficulty controlling bowel movements, haemorrhoids, dry mouth
• hepatitis and liver damage (including fatal liver failure), cholestasis, increased bilirubin levels
• blisters on the body or in the mouth, skin peeling, skin eruptions, painful redness of the skin, severe rash with skin swelling (including hands and feet)
• increased sensitivity to sunlight, urticaria, increased sweating, skin colour changes
• difficulty urinating
• vaginal bleeding, vaginal irritation, absence or heavy menstruation, breast pain, sexual impotence
• chills, facial swelling, tongue discoloration, thirst, dental problems
• dry eyes

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, Medical Devices and Biocidal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw; tel.: +48 22 49 21 301; fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Temozolomide Glenmark

Keep this medicine out of sight and reach of children, preferably in a locked cabinet.
Accidental ingestion of the medicine may be fatal to a child.
Do not use this medicine after the expiry date stated on the sachet label after "EXP" and on the cardboard box after "Expiry date (EXP)". The expiry date refers to the last day of the stated month.
Sachet
Temozolomide Glenmark, 5 mg and 20 mg: Store below 25°C.
Temozolomide Glenmark, 100 mg, 140 mg, 180 mg, 250 mg: Store below 30°C.
Inform the pharmacist of any changes in the appearance of the capsules.
Do not dispose of medicines via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the Packaging and Other Information

What Temozolomide Glenmark Contains
The active substance is temozolomide.

• Temozolomide Glenmark 5 mg: each hard capsule contains 5 mg of temozolomide.
• Temozolomide Glenmark 20 mg: each hard capsule contains 20 mg of temozolomide.
• Temozolomide Glenmark 100 mg: each hard capsule contains 100 mg of temozolomide.
• Temozolomide Glenmark 140 mg: each hard capsule contains 140 mg of temozolomide.
• Temozolomide Glenmark 180 mg: each hard capsule contains 180 mg of temozolomide.
• Temozolomide Glenmark 250 mg: each hard capsule contains 250 mg of temozolomide.

The other ingredients are:
Capsule contents: lactose, anhydrous colloidal silica, sodium carboxymethyl starch (Type A), tartaric acid, stearic acid.
Capsule shell, size 0:
Temozolomide Glenmark 5 mg: gelatin, titanium dioxide (E 171), iron oxide yellow (E 172), indigo carmine (E 132)
Temozolomide Glenmark 20 mg: gelatin, titanium dioxide (E 171), iron oxide red (E 172), iron oxide yellow (E 172)
Temozolomide Glenmark 100 mg: gelatin, titanium dioxide (E 171), iron oxide red (E 172), indigo carmine (E 132)
Temozolomide Glenmark 140 mg: gelatin, titanium dioxide (E 171), indigo carmine (E 132)
Temozolomide Glenmark 180 mg: gelatin, titanium dioxide (E 171), iron oxide red (E 172), iron oxide black (E 172), iron oxide yellow (E 172)
Temozolomide Glenmark 250 mg: gelatin, titanium dioxide (E 171)

Printing ink:
Black ink: shellac, macrogol, concentrated ammonium hydroxide, potassium hydroxide, iron oxide black (E172)

What Temozolomide Glenmark Looks Like and Contents of the Packaging
Temozolomide Glenmark 5 mg: hard gelatin capsules of size 0, with a green cap and white body. The number "5" is printed in black ink on the body.
Temozolomide Glenmark 20 mg: hard gelatin capsules of size 0, with an orange cap and white body. The number "20" is printed in black ink on the body.
Temozolomide Glenmark 100 mg: hard gelatin capsules of size 0, with a violet cap and white body. The number "100" is printed in black ink on the body.
Temozolomide Glenmark 140 mg: hard gelatin capsules of size 0, with a blue cap and white body. The number "140" is printed in black ink on the body.
Temozolomide Glenmark 180 mg: hard gelatin capsules of size 0, with a chocolate-brown cap and white body. The number "180" is printed in black ink on the body.
Temozolomide Glenmark 250 mg: hard gelatin capsules of size 0, with a white cap and white body. The number "250" is printed in black ink on the body.

Blister pack
Aluminum/Paper/LDPE/Ethylene and acrylic acid copolymer foil blister. Each blister contains 1 hard capsule. The blisters are packed in a cardboard box. The cardboard box contains 5 hard capsules individually packed in blisters.

Marketing Authorisation Holder
Glenmark Pharmaceuticals s.r.o.
Hvězdova 1716/2b
140 78 Prague 4
Czech Republic

Manufacturer
EirGen Pharma Ltd.
Westside Business Park, Old Kilmeaden Road
Waterford, X91 YV67
Ireland
Glenmark Pharmaceuticals s.r.o.
Fibichova 143
566 17 Vysoké Mýto
Czech Republic

For more detailed information about this medicine, please contact the representative of the Marketing Authorisation Holder:
Glenmark Pharmaceuticals Sp. z o.o.
ul. Osmańska 14
02-823 Warsaw
Poland